NCT01633957

A Trial of Genotype-based Warfarin Initiation in Patients With Mechanical Prosthetic Heart Valve

Academic Leader，Head of Cardiac Surgery,Principal Investigator, Clinical Professor

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Xi Zhang · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Until very recently, warfarin is still the best drug of choice for long-term anticoagulation for patients with mechanical prosthetic heart valve. However, the complication of warfarin account for 75 percent of the whole complication after the mechanical prosthetic heart valve replacement. Interindividual variation in warfarin dose is mediated by multiple factors.Advanced models using combinations of clinical attributes and genetic factors(CYP2C9, VKORC1, and CYP4F2) explain 50-75% of variability in warfarin dose requirements.These warfarin dosing models have the potential to improve patient safety by reducing or eliminating serious adverse events. The investigators conducted a prospective, randomized, blinded, two arm trial to test this hypothesis.

Conditions

• Anticoagulation Treatment Overdose
• Heart Valve Diseases

Interventions

Type	Name	Description
OTHER	Genotype-based Warfarin Initiation model	Based on previous retrospective study,investigators established a genotype-based warfarin model to estimate the drug dosage.
OTHER	clinical factor-based warfarin initiation model	Based on previous retrospective study,investigators established a clinical factor-based warfarin model to estimate the drug dosage.

Timeline

• Start date: 2012-06-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2012-07-06
• Last updated: 2016-07-25

Locations

1 site across 1 country: China